Kornimate/medical-research-clean huggingface dataset:
interest of navigation for the treatment of pertrochanteric fractures with the gamma 3 nail

Conditions: Femoral Fractures; Fracture Fixation, Internal; Trochanteric Fractures

Summary: the aim of the study is to compare tip-apex distance values in two groups of patients after intramedullary nailing of proximal femur. the first group of patients is operated with the help of a 3d reconstruction device connected to the standard fluoroscopy allowing the surgeon to visualize directly the exact position of the tip of the trans-cervical screw while the second group (which is the reference-group) is operated with the help of fluoroscopy alone.

the main orthopedic complication after fixation of a proximal femoral fracture with a cephalo-medullary nail is the cut-out of the cephalic screw from femoral head resulting in a protrusion of this screw in the coxo-femoral joint, mostly during the first 6 months after the operation. in most cases, the surgeon has to remove the primary implant and perform a total hip arthroplasty to his patient, therefore rising the morbidity and social costs linked to the treatment of the initial fracture. baumgartner showed the importance of the position of the cephalic screw for predicting failure of the implant and proposed a new measurement to evaluate this position, the tip-apex distance which is the sum of the distance from the tip of the cephalic screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. he showed a lower tad was associated with a lower risk of cut-out. the aim of this study is to evaluate the help of a 3d reconstruction software linked to the standard fluoroscopy in achieving the lowest tad and therefore minimizing the cut-out rate.

Eligibility criteria:
inclusion criteria: * adult patients with a proximal femoral fracture eligible for intramedullary nailing with a gamma 3 nail exclusion criteria: * none

Keywords: navigation gamma nail
proof of concept study on the efficacy of inhalatory targeted imatinib nanoformulations in pulmonary hypertension and post-inflammatory fibrosis.

Conditions: Pulmonary Arterial Hypertension (PAH); Lung Fibrosis Interstitial

Summary: the promptly study is a proof-of-concept research project evaluating the efficacy of xhalip, an innovative inhalable formulation of imatinib, in treating pulmonary arterial hypertension (pah) and post-inflammatory fibrosing lung diseases (lfd). main objective to demonstrate the ability of xhalip to improve the prognosis of pah and lfd by reducing pulmonary fibrosis and vascular remodeling. key research questions is xhalip effectively absorbed by pathological lung cells? does it have a beneficial biological effect on cell proliferation and extracellular matrix deposition? study plan preclinical phase: in vitro tests on cells obtained from patients with pah and lfd. absorption and distribution analysis: in vitro lung tissue models to assess drug penetration and effectiveness. biological activity assessment: evaluating xhalip's ability to inhibit epithelial-mesenchymal transition and cell proliferation. participants patients aged ≥ 18 years diagnosed with pah or lfd, either candidates for or recipients of lung transplantation. biological samples (bronchoalveolar lavage and explanted lung tissues). methodology confocal microscopy and flow cytometry to analyze absorption. rt-pcr and western blot to assess biological efficacy. alveolo-capillary models to test drug release and distribution. the study aims to translate preclinical findings into a potential future clinical trial for the development of xhalip as a novel inhalation-based therapeutic strategy for rare lung diseases.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years diagnosed with fibrosing lung disease, obliterative bronchiolitis, or pah, who are candidates for or have undergone lung transplantation. * obtaining informed consent for all patients enrolled prospectively and all those enrolled retrospectively at their first clinical occurrence at our center. exclusion criteria: * suspected or confirmed diagnosis of pulmonary neoplastic disease.

Keywords: pah lfd pulmonary arterial hypertension lung fibrosis desease xhalip imatinib
real-world study on edoxaban treatment for patients with non-valvular atrial fibrillation in china

Conditions: Non-valvular Atrial Fibrillation

Summary: the safety of edoxaban treatment will be examined using real-world clinical evidence from adult patients with non-valvular atrial fibrillation (nvaf) indications in routine clinical practice.

this non-interventional, observational study will evaluate the safety of edoxaban treatment in adult patients with nvaf indications with one or more risk factors. the primary objective of the study is to collect and evaluate safety data up to 2 years in a real-world setting in relation to adverse event onset (related to edoxaban treatment), duration, severity, and outcome. the secondary objective will evaluate the effect of edoxaban treatment on stroke (ischemic and hemorrhagic), systemic embolic event (see), transient ischemic attack (tia), major adverse cardiovascular events (mace), venous thromboembolism (vte), acute coronary syndrome (acs), hospitalization related to cardiovascular condition, extent of exposure and compliance to edoxaban therapy, and rate and reasons of permanent discontinuation of edoxaban therapy.

Eligibility criteria:
inclusion criteria: * written, informed consent * nvaf-patients treated with edoxaban according to packaging information (i.e., for nvaf adult patients with one or more risk factors (such as history of congestive heart failure, hypertension, age ≥75 years old, diabetes, prior stroke or tia) in prevention of stroke and systemic circulation embolism) * not participating in any interventional study at the same time exclusion criteria: * not applicable

Keywords: non-valvular atrial fibrillation edoxaban
special drug use investigation for arixtra (fondaparinux) abdominal general surgery

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing general surgery of the lower limb at high risk of developing venous thromboembolism.


Eligibility criteria:
inclusion criteria: * patients undergoing general surgery of the lower limb at high risk for venous thromboembolism exclusion criteria: * patients with a history of hypersensitivity to the ingredients of fondaparinux * patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed) * patients with acute bacterial endocarditis * patients with severe renal impairment
ivm with low cost priming, enhanced oocyte recovery, and delayed transfer

Conditions: Polycystic Ovary Syndrome

Summary: a protocol was developed to improve pregnancy results after ivm compared to results from studies in the literature. differences from most published protocols include the use of the steiner-tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of fsh, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. eligible patient have a pco pattern in their ovaries during transvaginal ultrasound.

all participants are candidates for ivf having pcos or having pco patterns in their ovaries who wish to undertake ivm for the potential advantages that it holds. all cycles are proceeded by oral contraceptive use for cycle scheduling purposes. priming is done with oral letrozole with the addition of 25-75 iu daily starting after 2 days of letrozole. hcg is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. oocyte retrieval is done approximately 38 hours later. a steiner-tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. oocytes are assessed for maturity for up to 48 hours post retrieval. if mature, oocytes are injected with sperm using icsi. embryos are grown to blastocysts and all blastocyst are vitrified. warmed cryo-preserved blastocyst are transferred using routine ivf protocols during a subsequent cycle.

Eligibility criteria:
inclusion criteria: * pco pattern with \> 25 antral follicles * amh \> 3.5 exclusion criteria: * bmi \> 35 * body morphology making transvaginal retrieval difficult or impossible * complicating medical condition making pregnancy or ivf relatively contra-indicated

Keywords: ivm in vitro maturation polycystic ovarian syndrome pcos steiner-tan needle oocyte maturation
optimal treatment for women with a persisting pregnancy of unknown location

Conditions: Persistent Pregnancy of Unknown Location; Ectopic Pregnancy

Summary: this is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (ppul), which makes them at-risk for ectopic pregnancy. we will recruit hemodynamically stable women with a confirmed ppul to be randomized to one of three strategies: 1) uterine evacuation followed by methotrexate (mtx) for some (those that have evidence of a non visualized ectopic pregnancy) 2) empiric treatment with mtx for all 3) expectant management. randomization will be 1:1:1 into these three arms. after randomization, they will be followed and treated clinically as is indicated by the progression of their condition. primary outcome measures: uneventful decline of hcg to 5 iu/ml.


Eligibility criteria:
inclusion criteria: * female with a persisting pregnancy of unknown location: * a pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. a definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. ultrasound must be performed within 7 days prior to randomization. * persistence of hcg is defined as at least 2 serial hcg values (over 2-14 days), showing \< 15% rise per day, or \< 50% fall between the first and last value. * patient is hemodynamically stable, hemoglobin \>10 mg/dl * greater than or 18 years of age exclusion criteria: * hemodynamically unstable in need of acute treatment * most recent hcg \> 5000 miu/ml * patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion) * diagnosis of gestational trophoblastic disease * subject unwilling or unable to comply with study procedures * known hypersensitivity to mtx * presence of clinical contraindications for treatment with mtx * prior medical or surgical management of this gestation * subject unwilling to accept a blood transfusion
comparison of remowell 2 and inspire on delirium and cognitive dysfunction

Conditions: Cardiac Surgery; Cardiopulmonary Bypass

Summary: age is no longer an absolute contraindication to cardiac surgery therefore there is often need for combined interventions (double valve repair/replacement, or coronary artery bypass graft and valve repair/replacement) with relative prolongation of cardiopulmonary bypass time. prolonged cardiopulmonary bypass use causes an increase in the inflammatory response, and on the other a need for blood reinfusion and therefore lipid microemboli from the operative field. the clinical consequences for patients are post-operative delirium and post-operative cognitive impairment. these two neurological complications involve up to 45% of elderly patients undergoing cardiac surgery and have a significant impact on quality of life, hospitalization and mortality in the short and long term. the remowell 2 oxygenator system has demonstrated in preliminary studies that, compared to the gold standard inspire oxygenator, it can guarantee a significant reduction of hemodilution, inflammatory systemic response and embolization of lipid microemboli and leukocytes. in light of these considerations, it is possible to formulate the hypothesis that the use of the remowell 2 device can contribute to significantly reducing the onset of post-operative delirium and cognitive impairment. the present study is designed to validate this hypothesis in a randomized controlled scenario.


Eligibility criteria:
inclusion criteria: 1. signature of informed consent for participation in the study 2. age ≥65 years 3. patients undergoing cardiac surgery of: 1. coronary artery bypass graft and concomitant valve replacement/repair or 2. double valve replacement/repair exclusion criteria: 1. any documented history of cognitive impairment estimated as a mini mental state examination \< 24 points 2. patients who need blood prime in the cardiopulmonary bypass circuit 3. chronic coagulopathies ( international normalized ratio \> 2 in patients without anticoagulant treatment) 4. end stage renal disease on dialysis treatment 5. previous cerebrovascular accident 6. active cancer or immunological diseases 7. liver cirrhosis (platelets \<100.000/ul) 8. decompensated diabetes 9. severe preoperative anemia (hemoglobin \<8 g/dl).
assessment of early-detection based on liquid biopsy in gastric cancer, ascend-gastric

Conditions: Cancer

Summary: ascend-gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free dna (cfdna), circulating tumor dna (ctdna) mutation and circulating rna. the study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.


Eligibility criteria:
inclusion criteria for cancer arm participants: * age 40-75 years at the day of consenting to the study. * able to provide a written informed consent. * no prior cancer treatment (local or systematic) with either of the following: a. pathologically confirmed cancer diagnosis within 42 days prior to blood draw. b. high suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw. exclusion criteria for cancer arm participants: * insufficient qualified blood samples. * during pregnancy or lactation. * recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. * recipient of blood transfusion within 7 days prior to blood draw. * recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw. * with other known malignant tumors or multiple primary tumors. inclusion criteria for benign disease arm participants: * age 40-75 years at the day of consenting to the study. * able to provide a written informed consent. * able to provide sufficient and qualified blood samples for study tests. * have either of the following: a. pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection. b. high suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw. exclusion criteria for benign disease arm participants: * insufficient qualified blood sample for study test. * during pregnancy or lactation. * recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. * recipient of blood transfusion within 7 days prior to study blood draw. * recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.

Keywords: cancer liquid biopsy cell-free dna (cfdna) methylation circulating tumor dna (ctdna) mutation whole blood mirna
added value of patient-specific computer simulation in transcatheter aortic valve implantation (tavi)

Conditions: Aortic Valve Stenosis

Summary: transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. as patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. this, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. this necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. patient-specific computer simulation may improve outcome of tavi by proposing the valve size that best fits the individual patient. the aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.


Eligibility criteria:
inclusion criteria: * native severe aortic valve stenosis * planned for tavi with the evolut r valve exclusion criteria: * bicuspid aortic valve * extensive subannular calcifications * non-transfemoral access * poor ct quality * lack of written informed consent

Keywords: tavi computer simulation
evaluation of earlysense; a contact-less heart and respiration rate monitoring in sleep lap examined

Conditions: Over Weight; Sleep Disorders

Summary: the objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the earlysense system vs. the standard system, and predicate device for earlysense (embla) used in sleep lab in monitoring heart rate and respiration rates monitors (ecg, respiratory belts, oximeter) that are currently used in the sleep lab among different population (obese, patients with or without apnea, patients with or without arrhythmia). it is emphasized that no interpretations or clinical decisions will be made based on data received from the es study device.

the study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the earlysense system vs. the monitors used in sleep lab (e.g., polysomnography, respiratory belts, ecg, etc..) . data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by earlysense contactless monitor. different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Eligibility criteria:
inclusion criteria: * 1. age 18 years or more 2. is willing to sign the consent form. exclusion criteria: * age \< 18 years * is not willing to sign the consent form.
definite stent thrombosis in comatose out of hospital cardiac arrest survivors

Conditions: Out of Hospital Cardiac Arrest; Stent Thrombosis; Drug Eluting Stent; Therapeutic Hypothermia

Summary: reliable data on stent thrombosis (st) in comatose out of hospital cardiac arrest (ohca) survivors is lacking. in comatose ohca survivors suspicion of st can be made with precise clinical monitoring of the patient with definite confirmation being possible only by coronary angiography or autopsy of deceased patients. however in addition to definite st which can be confirmed using current protocols, additional st which are clinically silent are plausible. these could be identified only by systematic coronary angiography of all ohca survivors or by autopsy of deceased patients. collectively with definite st confirmed by coronary angiography upon clinical suspicion the incidence of all forms of st in survivors of ohca treated with pci and hypothermia could be obtained. consecutive comatose survivors of ohca treated with percutaneous coronary intervention (pci) and hypothermia will be included. all study participants will receive treatment per our established clinical protocol and will be followed for 10 days. in all patients in whom clinical suspicion of st will be made immediate coronary angiography and if necessary pci will be carried out. in all patients that will die in the observed period of 10 days autopsy will be performed. survivors however will have an additional control coronary angiography on 10th day after admission, to assess presence of clinically silent st. we expect that the incidence of true definitive st in comatose ohca survivors treated with urgent pci with stenting and hypothermia is greater than one, which is confirmed on the basis of clinical suspicion by angiography or later with autopsy.


Eligibility criteria:
inclusion criteria: * comatose out-of-hospital cardiac arrest survivors admitted to university medical centre ljubljana * treated with primary pci with stenting * treated with therapeutic hypothermia. exclusion criteria: * younger than 18 years old.

Keywords: stent thrombosis
screening of specific genes for pigmented villous nodular synovitis

Conditions: Pigmented Villonodular Synovitis

Summary: this study retrospectively analyzed the history of present illness of pvns patients in our hospital. the enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions. take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.

this study retrospectively analyzed the symptoms, time of onset, injury history, laboratory examinations, imaging examinations, and intraoperative conditions of pvns patients in our hospital. the enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions (vas score, sf-36 score). take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of pigmented villonodular synovitis. 2. clinical diagnosis of giant cell tumor of tendon sheath exclusion criteria: 1. no surgical treatment. 2. there were no pathological specimens during the operation. 3. the age of the patient is less than 18 years old or more than 60 years old. 4. the operation record shows nodular type.